# FDA recall Z-1042-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-12-03.

## Product

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal

## Reason for recall

Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

## Distribution

US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.

## Key facts

- **Recall number:** Z-1042-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-03
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1042-2026

## Citation

> AI Analytics. FDA recall Z-1042-2026. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-1042-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*